Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant

Infections Clinical Trial

Official title:

Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781779
• Other study ID #: STUDY00003363
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2020
• Source: Kansas City Heart Rhythm Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn how effective each of the two dressings, Silverlon® and AQUACEL® AG, are in preventing post cardiac implantable electronic devices (CIED) procedure wound infections.

Description:

This is a single center, prospective, 2-arm randomized, non-blinded study. A total of 100 participants will be assigned to the Silverlon arm and 100 to the AQUACEL AG arm.

The number of procedures to implant CIED has risen in recent years. With this rise has also brought a rise in post-procedure infections. Infections will happen and there is a continued need to improve all aspects of the surgery and post-operative care. Wound coverage with appropriate dressings is one aspect that needs to be studied in CIED implant patients. Silverlon and AQUACEL AG are two options of dressings available for these patients. This study will look to see if one of the two is a better option for post-operative CIED implant patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who are scheduled for a CIED implant, generator change, or upgrade at the University of Kansas Hospital

• Able to give informed consent

Exclusion Criteria:

• Patients who are already on antibiotics for another reasons

• Immunocompromised patients such as those on immunosuppressant's and HIV positive patients

• Patients who are post device explant for lead infection

• Patients with an allergy to adhesive, silver or an allergy to the dressing(s) or their components

Related Conditions & MeSH terms

• Infections
• Wounds and Injuries

Intervention

Device:
• Silverlon®
Silverlon wound dressings
• AQUACEL® AG
AQUACEL® AG wound dressings

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pocket Hematoma, Moderate-Severe	A pocket hematoma is an accumulation of blood in or near the surgical incision which occurs because of a defect in hemostasis such as injury to blood vessels. Pocket hematoma is associated with local discomfort, an increased risk of infection, and may require surgical intervention or lead to lengthier hospital stays.; Mild - Ecchymosis or mild effusion in the pocket, no swelling or pain to device-pocket (watchful waiting) Moderate - Large effusion in the pocket leading to swelling and causing functional impairment or pain to device-pocket Severe - Any pocket hematoma requiring: Reoperation and/or resulting in prolongation of hospitalization (defined as extended hospitalization or rehospitalization for >24 hours, postindex surgery, primarily due to hematoma) and/or requiring interruption of OAC (defined as reversal or intentional withholding, in response to pocket hematoma, resulting in subtherapeutic anticoagulation for >24 hours)	7-10 days post implant
Secondary	Wound Drainage	Number of participants with wound drainage	At time of dressing removal, up to 10 days post operative
Secondary	Pocket Dehiscence	Pocket (Wound) Dehiscence: Dehiscence is a partial or total separation of previously approximated wound edges, due to a failure of proper wound healing. It may be just the surface layer or the whole wound.This scenario typically occurs 5 to 8 days following surgery when healing is still in the early stages.	At time of dressing removal, up to 10 days post operative
Secondary	Rash After Removal	Number of participants with rash after dressing removal	At time of dressing removal, up to 10 days post operative
Secondary	Site Itching/Burning	Number of participants with Site itching/burning	At time of dressing removal, up to 10 days post operative
Secondary	Skin Erythema	Number of participants with skin erythema	At time of dressing removal, up to 10 days post operative